Author: Elena Filimonova, Chief Marketing Officer
Snapshot:
- Hybrid Trial Designs: The industry is shifting towards hybrid trials, recognizing the balance between virtual and in-person elements to enhance patient accessibility and trial effectiveness.
- Revolutionary Innovations in Medicine: mRNA technology and other transformative therapies are reshaping treatment paradigms, necessitating adaptive and thoughtful clinical research approaches.
- AI's Growing Influence: The adoption of AI in clinical research will lead to increased drug development efficiency and the use of computer simulations, while still requiring careful human oversight to manage risks and ethical concerns.
Reflecting back on last year, 2023 was tumultuous. In all likelihood, 2024 will be as well. But change produces possibility and growth.
It’s in that vein of exploring what will matter for us as people and for clinical research that I sat down with our CEO, Jagath Wanninayake. We discussed the trends he is seeing that will define 2024, and their impact on clinical trials. Here are a few snippets from our conversation.
Elena Filimonova: What are the big trends in clinical trials that you’re anticipating for 2024?
Jagath Wanninayake: I’m expecting three big trends to define this year. They’re not new; they are all continuations of what we have seen over recent years and months, and I expect we will see significant advancements this year.
- First, one change I’m seeing is the shift in discussion from prioritizing completely virtual trial designs to the realization that, in many cases, hybrid trials are a better approach.
- Second, we will continue to see transformative innovation in medicine and science, bringing novel therapies like CAR-T cell therapies, mRNA-based treatments, or gene therapy using CRISPR. That means that clinical research needs to match these innovations with pragmatic execution of studies.
- And third, practically applied artificial intelligence (AI) will continue to impact clinical research, and we will only see its influence grow in 2024 and beyond.
EF: Let’s talk a little more about hybrid approaches. What are you seeing and how is this different than what the industry has experienced previously?
JW: Well, as you’re alluding to, virtual trials, decentralized trials (DCT), and hybrid trials have been around for several years, and of course became especially important during the COVID pandemic.
While there was a lot of excitement around DCT, people are waking up to the difficulty and the impracticality of 100% virtual trials. The “all or nothing, virtual or bust” concept has gone away. At the same time, the industry recognizes that virtual elements of a trial can make them more accessible to patients. And the reality is setting in that hybrid is the way to go. Even in oncology, a senior FDA official was talking about how virtual elements in a trial have shown to be very successful in hybrid designs for cancer patients. This demonstrates the continued importance of pragmatic innovation and taking a measured approach to apply new developments in clinical research.
EF: The shift from virtual to hybrid trials feels like an evolution in the clinical research process, not a revolution. But we are seeing revolutionary innovation in the science. What advancements will be most important in the coming year, and what are the implications for Suvoda and the clinical research sector?
JW: This is what I am fascinated by and passionate about in this business. The life science industry has evolved through transformational moments. The big step changes, like someone discovering something in a petri dish of mold (penicillin) transformed how we live life. Pre-penicillin, post-penicillin; pre-anesthesia, post-anesthesia.
One such revolution right now is around mRNA. It is fundamentally changing how we treat disease. mRNA is a means of inducing or modulating the immune response of the body, and it's not only related to vaccines, it's going to be in many different therapeutic areas. Oncology and infectious disease are going to benefit from mRNA, and that's why a lot of companies are working on these types of treatments.
So, penicillin, mRNA, CRISPR - those are big transformational step changes. Once that step change happens, there's incremental innovation that follows. The science side of pharma is about revolution. But, the execution side of it, how that science gets brought to diverse human beings, has to be thoughtful, to manage risk, and to prioritize ethics.
EF: In many ways, 2023 felt like the year of AI. How will AI impact clinical research, and how can this revolutionary technology be applied with the pragmatism and risk management that is essential for clinical trials?
JW: AI adoption is going to lead to several orders of magnitude of transformation over the coming years. This is a secular trend across industries that will, of course, play a role in clinical research as well. First, AI is going to increase the volume of compounds in preclinical research, many of which will transition into the clinical stage. Many pharma companies are looking to leverage AI to help identify promising indications for novel compounds, or for combinations of drugs. We should see an increase in the number of trials with more promising drugs because AI can generate insights so quickly from historical and current data.
At the same time, I expect we’re going to start seeing more focus on clinical trials utilizing computer simulations. As AI gets better, and as we have better data around how human beings have responded to a plethora of compounds that have been tested over the last decades of clinical trials, there's going to be a body of knowledge and data around biological response to compounds. So you will be able to generate synthetic patient data with a reasonable degree of accuracy and run trials with smaller patient populations to get to that point of understanding how this drug works in actual humans much more quickly.
Lastly, we have to approach AI augmentation pragmatically, understanding that we need a human guide to manage risk around AI hallucinations, errors, and ethics for patients. AI will augment human work with automation, efficient data analysis, and process improvements, so that today’s scientific, clinical, and technology teams can be more efficient, thoughtful, and creative in their roles.
Author
Elena Filimonova
Chief Marketing Officer Suvoda